NCCN Evidence Blocks™ User Guide In cancer care, the most important value perspective is that of the individual patient. NCCN Evidence Blocks™ educate providers and patients about the efficacy, safety, and affordability of systemic therapy. NCCN Evidence Blocks™ are a starting point for shared decision-making based on a common vocabulary of choices and values. The NCCN Evidence Blocks™ are published in a new version of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and are intended as a visual representation of five key value measures that provide important information about specific NCCN Guidelines® recommendations: efficacy, safety, quality and quantity of evidence, consistency of evidence, and affordability. By adding affordability to the existing National Comprehensive Cancer Network® (NCCN®) criteria for evaluating treatment options, patients will be empowered to identify, alongside their physician, optimal treatment based on clinical and economic considerations that are of most value to them. NCCN Guidelines with NCCN Evidence Blocks™ are an additional NCCN resource—separate from the NCCN Guidelines— that are currently available free of charge on NCCN.org. NCCN intends for the library of NCCN Guidelines with NCCN Evidence Blocks™ for systemic therapies to be published by the end of 2017. For more information, visit NCCN.org/EvidenceBlocks. NCCN Guidelines Version 1.2016 Chronic Myelogenous Leukemia TM TM NCCN EVIDENCE BLOCKS CATEGORIES ANDBlocks DEFINITIONS NCCN Evidence 5 4 3 2 1 NCCN Guidelines Index CML Table of Contents NCCN EVIDENCE BLOCKS EXAMPLEDiscussion TM 5 NCCN EVIDENCE BLOCKS CATEGORIES AND DEFINITIONS E = Efficacy of Regimen/Agent 4 5 E = Efficacy of Regimen/Agent S = Safety of Regimen/Agent S = Safety of Regimen/Agent 4 3 Q = Quality of EvidenceQ = Quality of Evidence 3 2 C = Consistency of Evidence C = Consistency of Evidence 2 1 A = Affordability of Regimen/Agent A = Affordability of Regimen/Agent 1 E S Q C A E S Q C A Efficacy of Regimen/Agent © 2015 National Comprehensive Cancer Network® 5 Highly effective:Oftenprovideslong-termsurvivaladvantage or has curative potential 4 Very effective: Sometimesprovideslong-termsurvival advantage or has curative potential 3 Moderately effective: Modest, no, or unknown impact on survival but often provides control of disease 2 Minimally effective: Modest, no, or unknown impact on survival and sometimes provides control of disease 1 Palliative:Providessymptomaticbenefitonly Safety of Regimen/Agent 5 Usually no meaningful toxicity: Uncommon or minimal side effects.Nointerferencewithactivitiesofdailyliving(ADLs) 4 Occasionally toxic:Raresignificanttoxicitiesorlow-grade toxicities only. Little interference with ADLs 3 Mildly toxic: Mild toxicity that interferes with ADLs is common 2 Moderately toxic:Significanttoxicitiesoftenoccur;life threatening/fatal toxicity is uncommon. Interference with ADLs is usual 1 Highly toxic: Usuallysevere,significanttoxicitiesorlife threatening/fatal toxicity often observed. Interference with ADLs is usual and/or severe NCCN.org/EvidenceBlocks E=4 Example Evidence Block S=4 5 E=4 Q=3 S=4 4 Q=3 C=4 3 C=4 A=3 2 A=3 1 E S Q C A E S Q C A ® © 2015 National Comprehensive Cancer Network Quality of Evidence 5 High quality: Multiplewell-designedrandomizedtrialsand/or meta-analyses 4 Good quality:Severalwell-designedrandomizedtrials 3 Average quality:Lowqualityrandomizedtrialsorwelldesignednon-randomizedtrials 2 Low quality: Case reports or clinical experience only 1 Poor quality: Little or no evidence Consistency of Evidence 5 Highly consistent: Multiple trials with similar outcomes 4 Mainly consistent: Multiple trials with some variability in outcome 3 May be consistent: Fewtrialsoronlytrialswithfewpatients; lowerqualitytrialswhetherrandomizedornot 2 Inconsistent: Meaningful differences in direction of outcome between quality trials 1 Anecdotal evidence only: Evidence in humans based upon anecdotal experience Affordability of Regimen/Agent (includes drug cost, supportive care, infusions, toxicity monitoring, management of toxicity) 5 4 3 2 1 Very inexpensive Inexpensive Moderately expensive Expensive Very expensive Version 1.2016, 09/09/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Evidence BlocksTM, NCCN Guidelines®, and this illustration may not be reproduced in any form without the express written permission of NCCN®. EB-1
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